The EVE-PMS technology is intended for determination of intolerance or sensitivity to sex hormones, among women suffering from severe PreMenstrual Syndrome (PMS).

The system includes skin testing panel for identification of hormones to which the patients might be sensitive. Tests are applied close to the ovulation period and the skin reaction is examined in 20 minutes, 48 hours and daily during the following month. Results of skin tests and patient's history will determine the value of EVE-PMS Skin-Test Panel as a diagnostic tool for severe PMS patients.

Skin testing 4 sex hormones will be performed during the luteal phase of the subject's menstrual cycle by study investigators.

Hormones:

Progesterone 1mmol/L

Estradiol 1mmol/L

Estrone 3mmol/L

Estriol 3mmol/l

Controls:

Saline (NaCl) 0.9%

Ethyl Oleate with 10% Benzyl Alcohol

Histamine phosphate 1mg/ml (epicutaneous- prick test)

Other Names:

Progesterone

Estradiol

Estrone

Estriol

Experimental: PMS

Drug: Skin test panel

Hormones:

Progesterone 1mmol/L

Estradiol 1 mmol/L

Estrone 3 mmol/L

Estriol 3mmol/l

Controls:

Saline (NaCl) 0.9%

Ethyl Oleate with 10% Benzyl Alcohol

Histamine phosphate 1mg/ml (epicutaneous- prick test)

Other Names:

Progesterone

Estradiol

Estrone

Estriol

Eligibility

Ages Eligible for Study:

20 Years to 45 Years

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Person is over the age of 20 but not older than age 45.

Person is willing to participate as evidenced by signing the written informed consent form.

Suffers from known dominant severe symptom of breast swelling and tenderness (level 7-10 according to standard scale of PMS symptoms severity)

Other severe symptoms of Premenstrual syndrome (based on WHO and ACOG criteria). This may include one or more of PMS symptoms with level 7-10 according to standard scale of PMS symptoms severity.

At work, school, home, or in daily routine, at least one of the PMS symptoms caused reduction of productivity or inefficiency

At least one of the PMS symptoms caused avoidance of or less participation in hobbies or social activities

At least one of the PMS symptoms interfere with relationships with others:

i. Timing of PMS symptom(s): during the 14 days prior to onset of menstrual flow (rather than spotting) and up to 5 days during the menstrual flow.

ii. Pattern and length of PMS symptomatic period: minimum of 2 days, up to 14 days.

iii. For PMS diagnosis two out of last three consecutive menstrual cycles were monitored by daily monitoring of symptoms.

iv. Timing and length of asymptomatic phase: day 6 to at least day 10 of the menstrual cycle.

v. Cyclicity - presentation of the 'off-on' phenomenon: there should be a clear shift from no PMS symptoms to PMS symptoms.

vi. Reliable non hormonal contraception.

Exclusion Criteria:

Pregnant or lactating woman

Oral contraceptives during last three months, including hormonal IUD (trade name mirena).

Serious health problems.

Unexplained menstrual disorders.

Treated by hormones (estrogen and progesterone).

For healthy: Irregular or abnormal test results.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00866437